Skip to main content
Clinical Trials/NCT03207880
NCT03207880CompletedNot Applicable

Piloting an Innovation to Improve the Quality of Remote Abortion Services: Incorporating Use of Multi-Level Pregnancy Tests

Gynuity Health Projects1 site in 1 country165 target enrollmentStarted: November 1, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
165
Locations
1
Primary Endpoint
Proportion of women who successfully receive the MLPTs

Study Overview

Brief Summary

Serial use of urine multi-level pregnancy tests (MLPTs) has been shown to be a reliable and efficient strategy for excluding ongoing pregnancy after medical abortion at ≤ 63 days of gestation. This pilot project will assess whether MLPTs can enhance the quality of remote medical abortion services through enabling women to reliably ascertain their abortion outcomes at home sooner than would otherwise have been the case.

safe2choose provides remote medical abortion services through the Internet (information, counselling and access to abortion pills) in a growing number of countries worldwide. safe2choose will collaborate with Gynuity Health Projects to pilot the utility of MLPTs for home follow-up as part of its remote medical abortion services.

As safe2choose does not have a physical office, the location of the sponsor's office is listed in this entry as the study location. Women from the United States are NOT eligible to enroll.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
— to 50 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Recipient of safe2choose medical abortion services
  • Able to read English or Spanish
  • ≤ 56 days LMP
  • Willing and able to read and sign consent form
  • Agree to comply with the study procedures, including completing the follow-up survey

Exclusion Criteria

  • Does not meet inclusion criteria

Outcomes

Primary Outcomes

Proportion of women who successfully receive the MLPTs

Time Frame: 1 week after mailing the MLPTs

Proportion of women who use the MLPTs to determine their abortion outcome

Time Frame: 2 weeks after receiving medical abortion package

Proportion of women able to use MLPTs on their own without guidance or instruction from providers

Time Frame: 2 weeks after receiving medical abortion package

Proportion of women who take action based on the interpretation of their test results

Time Frame: 2 weeks after receiving medical abortion package

Proportion of women who are satisfied with using MLPTs

Time Frame: 2 weeks after receiving medical abortion package

Secondary Outcomes

  • Proportion of all eligible safe2choose clients who elect to participate in the study(0 days after recruitment)
  • Proportion of women who find the MLPT instructions (written and video) to be helpful tools(2 weeks after enrollment)

Investigators

Sponsor
Gynuity Health Projects
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials